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Generated: November 21, 2018

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Details for New Drug Application (NDA): 018741

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NDA 018741 describes DIPROLENE, which is a drug marketed by Schering and Merck Sharp Dohme and is included in four NDAs. It is available from two suppliers. Additional details are available on the DIPROLENE profile page.

The generic ingredient in DIPROLENE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
Summary for 018741
Tradename:DIPROLENE
Applicant:Merck Sharp Dohme
Ingredient:betamethasone dipropionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018741
Suppliers and Packaging for NDA: 018741
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741 NDA Merck Sharp & Dohme Corp. 0085-0575 0085-0575-02 1 TUBE in 1 BOX (0085-0575-02) > 15 g in 1 TUBE
DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741 NDA Merck Sharp & Dohme Corp. 0085-0575 0085-0575-05 1 TUBE in 1 BOX (0085-0575-05) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT, AUGMENTED;TOPICALStrengthEQ 0.05% BASE
Approval Date:Jul 27, 1983TE:ABRLD:Yes

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